Skip to content

Trial · Interventional

CompletedPhase 1/2Registry data

A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration

Short name SPIOC-101

NCTNCT02314299 (opens ClinicalTrials.gov in a new tab)Other idSPIOC-101
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
20 participants (actual)
Sponsor
Stealth BioTherapeutics Inc. · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Nov 2014
Primary completion
May 2015
Completion
Jun 2015
First posted
11 Dec 2014 (estimated)
Last update posted
26 Oct 2015 (estimated)
Conditions
Diabetic Macular Edema · Age-related Macular Degeneration

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1/2

    SPIOC-101

    NCT02314299

    Nov 2014 to Jun 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one of the two treatment groups to determine the effects of topical ocular administration of low dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and Age-Related Macular Degeneration.

Interventions

  • MTP-131Drug

Arms2

  • Experimental

    Low Dose Regimen

    MTP-131 (Low Dose) sterile topical ophthalmic solution twice a day into the study eye

  • Experimental

    High Dose Regimen

    MTP-131 (High Dose) sterile topical ophthalmic solution twice a day into the study eye

Primary outcomes7

Outcomes the sponsor listed as primary.

  1. Incidence and severity of systemic and ocular adverse events

    Time frame · From Baseline to Day 28

  2. Change from Baseline in vital sign measurements

    Time frame · From Baseline to Day 28

  3. Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale

    Time frame · From Baseline to Day 28

  4. Change from Baseline in slit lamp examinations

    Time frame · From Baseline to Day 28

  5. Change from Baseline in intraocular pressure

    Time frame · From Baseline to Day 28

  6. Change from Baseline in dilated fundoscopic examinations

    Time frame · From Baseline to Day 28

  7. Change from Baseline in central subfield thickness

    Time frame · From Baseline to Day 28

Secondary outcomes(4)

  1. Change in central subfield thickness

    Time frame · From Baseline to Day 28

    Registry description

    Diabetic Macular Edema (DME) subjects only

  2. Change from Baseline in widefield angiography

    Time frame · From Baseline to Day 28

    Registry description

    Diabetic Macular Edema (DME) subjects only

  3. Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy

    Time frame · From Baseline to Day 28

    Registry description

    Age-Related Macular Degeneration (AMD) subjects only

  4. Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale

    Time frame · From baseline to Day 28

    Registry description

    All subjects

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * General: 1. Adults aged ≥18 and ≤ 80 years 2. Women of childbearing potential must have a negative urine pregnancy test at Baseline and agree to use a highly effective method of contraception throughout the study and 60 days after the last dose of study drug. * DME Treatment Group: 1. Central subfield thickness (CST) ≥325 microns as measured by spectral domain optical coherence tomography (SD-OCT) at Screening and Baseline Visits 2. BCVA (ETDRS) no better than 20/25 in the study eye 3. BCVA (ETDRS) no worse than 20/640 in either eye * AMD Treatment Group: 1. Non-exudative, intermediate age-related macular degeneration defined as an eye(s) having extensive intermediate drusen (10 or more drusen 63μm - 124μm) or large drusen (1 or more ≥125 μm) with no evidence of advanced AMD (i.e., no choroidal neovascularization or macular atrophy) 2. BCVA (ETDRS) no worse than 20/400 in either eye Exclusion Criteria: * General: 1. Inability to self-administer eye drops 2. Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve (for example deferoxamine, chloroquine/hydroxychloroquine \[Plaquenil\], tamoxifen, phenothiazines and ethambutol) 3. Any medical condition that, in the opinion of the investigator, would preclude safe participation in the study or completion of all study requirements and examinations 4. Have a glycosylated hemoglobin (HbA1c) ≥ 12% * Ocular Conditions: 1. Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity or successful completion of any study examination 2. Ocular hypertension or glaucoma, dry eye, and any other ocular pathology in the study eye requiring treatment with topical ophthalmic drops * Other protocol-defined inclusion/exclusion criteria may apply

PepBank is a research reference. Talk to a doctor before you use any peptide.